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Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes

Healing Hearts Together: Evaluating a Couples-based Intervention to Improve Health Outcomes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03938116
Enrollment
474
Registered
2019-05-06
Start date
2019-10-01
Completion date
2025-04-17
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

couple relationship, heart disease

Brief summary

The purpose of this study is to test the efficacy of the 8-week Healing Hearts Together (HHT) program to improve relationship quality, mental health, quality of life (QoL), and cardiovascular health. This is a randomized controlled trial in which couples are randomly assigned to the HHT group or usual care. Changes in the outcomes of interest will be assessed at the end of the intervention (8 weeks) and 6 months later.

Interventions

OTHERHealing Hearts Together

Participants in the HHT group will be assembled in groups and attend 8 weekly 2-hr sessions at UOHI led by 2 facilitators with psychology training. Sessions: 1) focus on understanding love, attachment, and their relationship to heart health; 2) provide an opportunity to share experiences related to cardiovascular disease with partners and peers; and 3) assist in identifying and improving communication patterns that may inhibit positive interactions and healthy behaviours. Participants are introduced to concepts through didactic presentations, videos, group and couple discussion and homework exercises. Participants will receive a folder containing copies of in-session and take-home exercises as well as the Hold Me Tight book to review between sessions.

Sponsors

Ottawa Heart Institute Research Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. University of Ottawa Heart Institute (UOHI) patients and their partners 2. Participants in a romantic relationship who are cohabiting (married, common-law or committed relationship for ≥1 year). No restrictions will be placed on sexual orientation. 3. Participants are ≥ 18 years of age 4. Participants are able to read and understand English (HHT materials are only available in English; once efficacy has been established, all materials will be translated to French). 5. Patients and partners are available to participate for the next 6 months (intervention and follow-up). 6. Patients and partners are able to provide informed consent.

Exclusion criteria

1. Participants who, in the opinion of the study psychologist, manifest psychiatric illness or cognitive impairment that would preclude participation in HHT (i.e. unable to benefit from the intervention; to prevent disruption of other participants). 2. Participants who are engaging in couples therapy or plan to engage in couples therapy in the next 6 months.

Design outcomes

Primary

MeasureTime frameDescription
Relationship quality: DAS8 weeksRelationship quality will be assessed using the DAS. The DAS is a validated 32-item questionnaire that measures couple satisfaction, cohesion, consensus and affectionate expression. Scores ≥108 are indicative of couple satisfaction, while scores ≤107 indicate distress.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026